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POSANOL is a brand name for Posaconazole, supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: POSANOL® (posaconazole) Solution for Injection, Delayed-Release Tablets and Oral Suspension are indicated for: Prophylaxis of Aspergillus and Candida infections in patients who are at high risk of developing these infections, such as patients with prolonged neutropenia or hematopoietic stem cell transplant (HSCT)…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The prescriber should follow the specific dosing instructions for each formulation. POSANOL® Solution for Injection should be administered via a central venous line, including a central venous catheter or PICC, by slow IV infusion over approximately 90 minutes.
If a central venous catheter is not available, a single infusion may be administered through a peripheral venous catheter by slow IV infusion over 30 minutes (see 7 WARNINGS AND PRECAUTIONS, General). POSANOL® Solution for Injection is not for IV bolus administration.
The tablet and oral suspension are not to be used interchangeably due to the differences in the dosing of each formulation. POSANOL® Delayed-Release Tablets may be taken with or without food. POSANOL® (posaconazole) Page 7 of 73 Each dose of POSANOL® Oral Suspension should be administered with a meal, or with a nutritional supplement in patients who cannot tolerate food to enhance the oral absorption.
For patients who cannot eat a full meal or tolerate an oral nutritional supplement and who do not have the option of taking POSANOL® Delayed-Release Tablets, an alternative antifungal therapy should be considered or patients should be monitored closely for breakthrough fungal infections.
Patients who have severe diarrhea or vomiting should be monitored closely for breakthrough fungal infections. Co-administration of drugs that can decrease the plasma concentrations of POSANOL® should generally be avoided unless the benefit outweighs the risk.
If such drugs are necessary, patients should be monitored closely for breakthrough fungal infections (see 9 DRUG INTERACTIONS). Pharmacokinetic modeling suggests that patients weighing greater than 120 kg may have lower posaconazole plasma drug exposure.
It is, therefore, suggested to closely monitor for breakthrough fungal infections. 2 Recommended Dose and Dosage Adjustment Recommended Dose Table 1 - Recommended POSANOL® Solution for Injection Dose According to Indication Indication Dose and Duration of Therapy Prophylaxis of Invasive Fungal Infections (IFIs) Loading dose of 300 mg (300 mg Solution for Injection) twice a day on the first day, then 300 mg (300 mg Solution for Injection) once a day thereafter.
Duration of therapy is based on recovery from neutropenia or immunosuppression. For patients with acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS), prophylaxis with POSANOL® should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm3.
). POSANOL® Solution for Injection is a single-dose unpreserved sterile solution. Therefore, from a microbiological point of view, once admixed, the product should be used immediately. If not used immediately, the solution can be stored up to 24 hours refrigerated 2°-8°C.
Equilibrate to room temperature. This medicinal product is for single use only and any unused solution should be discarded. A study was conducted to evaluate physical compatibility of POSANOL® Solution for Injection with injectable drug products and commonly used IV diluents during simulated Y-site infusion.
Compatibility was determined through visual observations, measurement of particulate matter and turbidity. Based on the results of the study, the following drug products can be infused at the same time through the same IV line (or cannula) as POSANOL® Solution for Injection: Amikacin sulfate Caspofungin Ciprofloxacin Daptomycin Dobutamine hydrochloride Famotidine Filgrastim Gentamicin sulfate Hydromorphone hydrochloride Levofloxacin Lorazepam Meropenem Micafungin Morphine sulfate Norepinephrine bitartrate Potassium chloride Vancomycin hydrochloride POSANOL® (posaconazole) Page 11 of 73 Any products not listed in the table above should not be co-administered through the same IV line (or cannula).
Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit. Once admixed, the solution of POSANOL® ranges from colorless to pale yellow. Variations of color within this range do not affect the quality of the product.
POSANOL® Tablet and POSANOL® Oral Suspension POSANOL® tablets and oral suspension are NOT interchangeable due to the differences in the dosing of each formulation. Follow the specific dosage recommendations for each of these formulations.
POSANOL® Delayed-Release Tablets and Oral Suspension are intended for oral administration only. POSANOL® Delayed-Release Tablets are specially designed for release in the small intestine. They should be swallowed whole, and should not be divided, crushed or chewed.
4 Drug-Drug Interaction 12/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
5 1 INDICATIONS ............................................................................................................. 1 Pediatrics..................................................................................................................
2 Geriatrics .................................................................................................................. 5 2 CONTRAINDICATIONS ................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 6 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................ 3 Reconstitution .......................................................................................................... 4 Administration .........................................................................................................
5 Missed Dose ........................................................................................................... 6 Image Acquisition and Interpretation .................................................................... 7 Instructions for Preparation and Use ....................................................................
Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph. There is no information regarding cross- sensitivity between POSANOL® and other azole antifungal agents.
Caution should be used when prescribing POSANOL® to patients with hypersensitivity to other azoles. POSANOL® (posaconazole) Page 6 of 73 Co-administration of POSANOL® and ergot alkaloids. POSANOL® may increase the plasma concentrations of ergot alkaloids, which may lead to ergotism (see 9 DRUG INTERACTIONS).
Co-administration of POSANOL® and certain medicinal products metabolized through the CYP3A4 system: terfenadine, astemizole, cisapride, pimozide and quinidine. Although not studied in vitro or in vivo, co-administration of these CYP3A4 substrates may result in increased plasma concentrations of those medicinal products, leading to potentially serious and/or life threatening adverse events, such as QT prolongation and rare occurrences of torsade de pointes (see 9 DRUG INTERACTIONS).
Co-administration of POSANOL® and HMG-CoA reductase inhibitors (statins) that are primarily metabolized through CYP3A4, since increased plasma concentration of these drugs can lead to rhabdomyolysis. Co-administration of POSANOL® and sirolimus.
Concomitant administration of POSANOL® with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Posaconazole in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Treatment of Refractory IFIs / Intolerant Patients with IFIs Loading dose of 300 mg (300 mg Solution for Injection) twice a day on the first day, then 300 mg (300 mg Solution for Injection) once a day thereafter. Duration of therapy should be based on the severity of the underlying disease, recovery from immunosuppression, and clinical response.
Table 2 - Dosing for POSANOL® Delayed-Release Tablet Indication Dose and Duration of Therapy Prophylaxis of Invasive Fungal Infections (IFIs) Loading dose of 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day thereafter.
Each dose may be taken without regard to food intake. The duration of therapy is based on recovery from neutropenia or immunosuppression. POSANOL® (posaconazole) Page 8 of 73 For patients with acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS), prophylaxis with POSANOL® should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm3.
Treatment of Refractory IFIs / Intolerant Patients with IFIs Loading dose of 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day thereafter. Duration of therapy should be based on the severity of the underlying disease, recovery from immunosuppression, and clinical response.
Table 3 - Dosing for POSANOL® Oral Suspension Indication Dose and Duration of therapy Prophylaxis of Invasive Fungal Infections (IFIs) 200 mg (5 mL) three times a day. The duration of therapy is based on recovery from neutropenia or immunosuppression.
For patients with acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS), prophylaxis with POSANOL® should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm3.
Treatment of Refractory IFIs / Intolerant Patients with IFIs 400 mg (10 mL) twice a daya In patients who cannot tolerate a meal or a nutritional supplement, POSANOL® should be administered at a dose of 200 mg (5 mL) four times a day.
Duration of therapy should be based on the severity of the underlying disease, recovery from immunosuppression, and clinical response. 5 mL) once a day for 13 days. a: Increasing the total daily dose of oral suspension above 800 mg does not further enhance the exposure to POSANOL®.
Dosage Adjustment Use in Renal Impairment The pharmacokinetics of POSANOL® Oral Suspension are not significantly affected by renal impairment. Therefore, no dose adjustment is necessary for oral dosing in patients with mild to severe renal impairment.
However, due to the variability in exposure with POSANOL® oral therapy, patients with severe renal impairment should be monitored closely for breakthrough fungal infections (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
In patients with moderate or severe renal impairment (eGFR <50 mL/min), receiving the POSANOL® Solution for Injection, accumulation of the IV vehicle, SBECD, is expected to occur. POSANOL® Solution for Injection should be avoided in patients with moderate or severe renal impairment (eGFR <50 mL/min), unless an assessment of the benefit/risk to the patient justifies the use […]
Shake POSANOL® Oral Suspension well before each use. 5 Missed Dose If a dose of this medication is missed, it should be taken as soon as possible. This will help to keep a constant amount of medication in the blood. However, if it is almost time for the next dose, it might be better to skip the missed dose and to go back to the regular dosing schedule.
5 OVERDOSAGE There is no experience with overdosage of POSANOL® Delayed-Release Tablets. During clinical trials, patients who received POSANOL® Oral Suspension doses up to 1,600 mg/day had no noted adverse reactions different from those reported with patients at the lower doses.
In addition, accidental overdose was noted in one patient who took 1,200 mg BID POSANOL® Oral Suspension for 3 days. No adverse reactions were noted by the investigator. In a trial of patients with severe hemodialysis-dependent renal dysfunction (Clcr < 20 mL/min), POSANOL® was not removed by hemodialysis.
Activated charcoal may be used to remove unabsorbed drug. For management of a suspected drug overdose, contact your regional poison control centre immediately. POSANOL® (posaconazole) Page 12 of 73 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 4 – Dosage Forms, Strengths, Composition and Packaging POSANOL® Solution for Injection POSANOL® Solution for Injection is available as a clear colorless to yellow liquid essentially free of foreign matter.
Each vial contains 18 mg of posaconazole per mL and the following inactive ingredients: Betadex Sulfobutyl Ether Sodium (SBECD), edetate disodium, hydrochloric acid, sodium hydroxide, and water for injection. 7 mL of solution (18 mg of posaconazole per mL; 300 mg/vial).
POSANOL® Solution for Injection must be diluted for IV administration. POSANOL® Delayed-Release Tablets POSANOL® Delayed-Release Tablet is a yellow-coated, capsule-shaped tablet debossed with "100" on one side. Each tablet contains 100 mg of posaconazole and the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, Opadry† II Yellow [consists of the following ingredients: polyvinyl alcohol partially hydrolyzed, Macrogol/PEG 3350 (polyethylene glycol 3350), titanium dioxide, talc, and iron oxide yellow], and silicon dioxide.
White HDPE bottle with a white PP child-resistant closure with pulp board liner with foil induction seal liner. Each 120 mL bottle contains 60 tablets. POSANOL® Oral Suspension POSANOL® Oral Suspension is a white, cherry flavored immediate-release suspension containing 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid Route of Administration Dosage Form / Strength Non-medicinal Ingredients intravenous (IV) solution for injection, 300 mg/vial (18 mg/mL) posaconazole Betadex Sulfobutyl Ether Sodium (SBECD), edetate disodium, hydrochloric acid, sodium hydroxide, and water for injection.
oral delayed-release tablets, 100 mg posaconazole Croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, Opadry† II Yellow [consists of the following ingredients: polyvinyl alcohol partially hydrolyzed, Macrogol/PEG 3350 (polyethylene glycol 3350), titanium dioxide, talc, and iron oxide yellow], and silicon dioxide.
suspension, 40 mg/mL posaconazole Artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum.
POSANOL® (posaconazole) Page 13 of 73 monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, […]
8 Radiation Dosimetry .............................................................................................. 11 5 OVERDOSAGE..........................................................................................................
11 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................. 1 Physical Characteristics .......................................................................................... 2 External Radiation ..................................................................................................
12 7 WARNINGS AND PRECAUTIONS ............................................................................... 1 Special Populations ................................................................................................ 1 Pregnant Women .............................................................................................
2 Breast-feeding .................................................................................................. 3 Pediatrics..........................................................................................................
4 Geriatrics .......................................................................................................... 13 8 ADVERSE REACTIONS...............................................................................................
1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................. 1 Clinical Trial Adverse Reactions – Pediatrics....................................................
3 Less Common Clinical Trial Adverse Reactions ...................................................... 1 Less Common Clinical Trial Adverse Reactions – Pediatrics ............................ 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data.............................................................................................................
5 Post-Market Adverse Reactions............................................................................. 28 9 DRUG INTERACTIONS .............................................................................................. 1 Serious Drug Interactions ......................................................................................
2 Drug Interactions Overview ................................................................................... 3 Drug-Behavioural Interactions ............................................................................... 4 Drug-Drug Interactions ..........................................................................................
5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions.........................................................................
37 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics ..........................................................................................
3 Pharmacokinetics ............................................................................................. 38 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 45 12 SPECIAL HANDLING […]